Cartilage and bone harvest and delivery system and methods

ABSTRACT

A system for harvesting bone material from a bone may include a rotary cutter defining a rotary cutter longitudinal axis extending between a rotary cutter proximal end and a rotary cutter distal end. The rotary cutter may have a drive shaft configured to receive input torque, and an osteochondral cutter configured to cut the tissue and receive the tissue material in response to rotation of the osteochondral cutter under pressure against the tissue. The system may further include a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation sized to closely fit over the osteochondral cutter. At least one of the bone port proximal end and the bone port distal end may be securable to the tissue. A stratiform tissue graft may be delivered through the bone port.

TECHNICAL FIELD

The present disclosure relates to systems, methods and devices for boneand cartilage harvesting and delivery. The present disclosure furtherrelates to systems, methods and devices for the repair of osteochondraldefects and bone defects.

BACKGROUND

Most surgical repairs of osteochondral lesions (i.e., bone-cartilagelesions) are performed using an antegrade approach, meaning that theapproach is from the cartilage side of the bone-cartilage defect. Inmany cases, because of the location of the lesion, these surgicalrepairs cannot be performed using an arthroscopic or minimally invasivetechnique; instead, these surgical repairs require an open procedure,increasing morbidity and the time required to recover from the surgery.

Another limitation of current surgical techniques for osteochondrallesion repair is the use of autograft or allograft osteochondral“plugs,” in which the plug is an intact specimen of cartilage withunderlying bone taken from a single anatomic site. In the case ofautograft osteochondral plugs, there are limitations to the size andnumber of plugs available in a patient. Furthermore, there is a notablerisk of morbidity at the plug harvest site, such as post-operative painand arthritic changes at the harvest site. In the case of allograftosteochondral plugs, there is a risk of an adverse immunologicalresponse as well as a risk of disease transmission.

Using a retrograde approach to surgically repair an osteochondrallesion, where the approach is from the bone side of the cartilage-bonedefect, has several advantages over an antegrade approach. One majoradvantage is that the retrograde approach can be performedarthroscopically. Another advantage is the opportunity to use the boneand cartilage that is removed to obtain access to the lesion asautograft material for the repair. Existing retrograde approaches aretechnically demanding and rarely used in clinical practice.

There is a need for a simpler, more reproduceable, more reliablesurgical technique for a retrograde approach for repairs ofosteochondral lesions. Additionally, there is a need for alternativeosteochondral graft materials that avoid the risks and complicationsassociated with the use of autograft or allograft osteochondral plugs.

SUMMARY

The various bone and cartilage harvesting and delivery devices, systems,and methods of the present disclosure have been developed in response tothe present state of the art, and in particular, in response to theproblems and needs in the art that have not yet been fully solved bycurrently available bone and cartilage harvesting and delivery devices,systems, and methods. In some embodiments, the bone and cartilageharvesting and delivery devices, systems, and methods of the presentdisclosure may provide improved bone and cartilage harvesting anddelivery methods for treating bone, cartilage and osteochondral defects.

According to some embodiments, a system for harvesting tissue material,including bone and cartilage tissue, from a body, may include a rotarycutter defining a rotary cutter longitudinal axis extending between arotary cutter proximal end and a rotary cutter distal end. The rotarycutter may have a drive shaft configured to receive input torque, and anosteochondral cutter configured to cut tissue and receive the tissuematerial in response to rotation of the osteochondral cutter underpressure against the tissue. The system may further have a bone portdefining a bone port longitudinal axis extending between a bone portproximal end and a bone port distal end. The bone port may have a boneport cannulation sized to closely fit over the osteochondral cutter. Atleast one of the bone port proximal end and the bone port distal end maybe securable to a bone.

The system may further include a plurality of additional rotary cutters,each of which comprises an osteochondral cutter having an outer diameterdifferent from an outer diameter of the rotary cutter, and a pluralityof additional bone ports, each of which comprises a bone portcannulation sized to closely fit over the osteochondral cutter of one ofthe plurality of additional rotary cutters.

The bone port distal end may be configured to be insertable into andretained in the bone.

The system may further include a bone pin comprising a distal endinsertable into the bone. The bone port proximal end may have a pinaperture sized to receive the bone pin to secure the bone port proximalend to the bone.

The system may further include a delivery tube defining a delivery tubelongitudinal axis extending between a delivery tube proximal end and adelivery tube distal end. The delivery tube distal end may be securableto the bone port proximal end such that the delivery tube longitudinalaxis is coaxial with the bone port longitudinal axis.

The system may further include a funnel with a funnel proximal endhaving a flared shape, and a funnel distal end securable to the boneport and/or the delivery tube.

The system may further include a cap securable to the bone port proximalend. The cap may have a cap port configured to allow instruments to passthrough the cap port while maintaining a leak resistant seal.

The system may further include a trial with a trial shaft with a trialshaft proximal end with a handle, and a trial shaft distal endinsertable into the bone port cannulation, and a trial tip andconfigured to approximate a topography of a cartilage or bone surface.The bone port cannulation may be sized to closely fit over the trialtip.

The system may further have a plurality of additional rotary cutters,each of which has an osteochondral cutter having an outer diameterdifferent from an outer diameter of the osteochondral cutter, aplurality of additional trial shafts, each of which has a trial shaftdistal end, and a plurality of additional bone ports, each of which hasa bone port cannulation sized to closely fit over the osteochondralcutter of one of the plurality of additional rotary cutters and toclosely fit over the trial shaft distal end of one of the plurality ofadditional trial shafts. The system may further include a plurality ofadditional trial tips, each of which is attachable to the trial shaftdistal end.

The plurality of additional trial tips may include at least a firsttrial tip with a first trial tip distal surface having a first shape, asecond trial tip with a second trial tip distal surface having a secondshape different from the first shape, and a third trial tip with a thirdtrial tip distal surface having a third shape different from the firstshape and the second shape.

The rotary cutter, the plurality of additional rotary cutters, the boneport, and the plurality of additional bone ports may all be configuredto be reusable. The trial shaft, the plurality of additional trialshafts, the trial tip, and the plurality of additional trial tips mayall be configured to be single-use.

The system may further have a trial with a trial shaft with a trialshaft proximal end having a handle, and a trial shaft distal endinsertable into the bone port cannulation, and a trial tip attachable tothe trial shaft distal end and configured to approximate a topography ofa cartilage surface. The bone port may have orientation markings. Atleast one of the trial shaft and the trial tip may have a trial timingmark that can be aligned with the orientation markings to orient atissue graft at a predetermined orientation relative to a graft site inwhich the tissue graft is to be placed.

According to some embodiments, a system for delivering a tissue graft toa graft site in a bone may have a bone port defining a bone portlongitudinal axis extending between a bone port proximal end and a boneport distal end. The bone port may have a bone port cannulation. Thesystem may further include a trial with a trial shaft having a trialshaft proximal end comprising a handle, and a trial shaft distal endinsertable into the bone port cannulation, and a trial tip configured toapproximate a topography of a cartilage surface. The bone portcannulation may be sized to closely fit over the trial shaft distal endand the trial tip. At least one of the bone port proximal end and thebone port distal end may be securable to the bone.

The bone port distal end may be configured to be insertable into andretained in the bone.

The system may further include a bone pin with a distal end insertableinto the bone. The bone port proximal end may have a pin aperture sizedto receive the bone pin to secure the bone port proximal end to thebone.

The system may further include a delivery tube defining a delivery tubelongitudinal axis extending between a delivery tube proximal end and adelivery tube distal end. The delivery tube distal end may be securableto the bone port proximal end such that the delivery tube longitudinalaxis is coaxial with the bone port longitudinal axis.

The system may further include a plurality of additional trial tipsincluding a first trial tip with a first trial tip distal surfaceoriented at a first angle, a second trial tip with a second trial tipdistal surface oriented at a second angle different from the firstangle, and a third trial tip with a third trial tip distal surfaceoriented at a third angle different from the first angle and the secondangle.

The bone port may have orientation markings. At least one of the trialshaft and the trial tip may have a trial timing mark that can be alignedwith the orientation markings to orient the tissue graft at apredetermined orientation relative to a graft site in which the tissuegraft is to be placed.

According to some embodiments, a system for preparing a tissue graft forinsertion in a bone may include a delivery tube defining a delivery tubeproximal end and a delivery tube distal end, a tamp with a tamp distalend insertable into the delivery tube proximal end, a base securable tothe delivery tube distal end, and a plurality of trial tips, each ofwhich is attachable to at least one of the base and the delivery tubedistal end. The delivery tube may be sized to fit closely over the tampdistal end and each trial tip of the plurality of trial tips. Theplurality of trial tips may include at least a first trial tip with afirst trial tip distal surface having a first shape, a second trial tipwith a second trial tip distal surface having a second shape differentfrom the first shape, and a third trial tip with a third trial tipdistal surface having a third shape different from the first shape andthe second shape.

Each of the plurality of trial tips may be attachable to the base, andthe base may be attachable to the delivery tube distal end.

The system may further include a bone port defining a bone portlongitudinal axis extending between a bone port proximal end and a boneport distal end. The bone port may have a bone port cannulation sized toclosely fit around the tissue graft. At least one of the bone portproximal end and the bone port distal end may be securable to the bone.The delivery tube distal end may be securable to the bone port proximalend.

The bone port may have orientation markings. The delivery tube may havea trial timing mark that can be aligned with the orientation markings toorient the tissue graft at a predetermined orientation relative to agraft site in which the tissue graft is to be placed.

According to some embodiments, a system for harvesting tissue materialfrom a body, preparing a tissue graft, and delivering the tissue graftto a graft site, may include a first rotary cutter defining a rotarycutter longitudinal axis extending between a rotary cutter proximal endand a rotary cutter distal end. The first rotary cutter may have a driveshaft configured to receive input torque, and an osteochondral cutterconfigured to cut tissue and receive the tissue material in response torotation of the osteochondral cutter under pressure against the tissue.The system may further include a bone port defining a bone portlongitudinal axis extending between a bone port proximal end and a boneport distal end, the bone port comprising a bone port cannulation, adelivery tube defining a delivery tube proximal end and a delivery tubedistal end, a base securable to the delivery tube distal end, and atrial. The trial may include a trial shaft with a trial shaft proximalend with a handle, and a trial shaft distal end. The trial may furtherinclude a trial tip attachable to the trial shaft distal end, and aplurality of additional trial tips, each of which is attachable to thebase and to the trial shaft distal end. At least one of the bone portproximal end and the bone port distal end may be securable to a bone.The bone port cannulation may be sized to closely fit over the trial tipand the osteochondral cutter. The delivery tube may be sized to fitclosely over the trial shaft distal end and each trial tip of theplurality of additional trial tips. The plurality of additional trialtips may include at least a first trial tip with a first trial tipdistal surface having a first shape, a second trial tip with a secondtrial tip distal surface having a second shape different from the firstshape, and a third trial tip with a third trial tip distal surfacehaving a third shape different from the first shape and the secondshape.

According to some embodiments, a method of treating an osteochondraldefect may include determining a local cartilage topography or a localsubchondral bone topography surrounding a perimeter of an osteochondraldefect, wherein the perimeter is circumscribed by a tunnel with aretrograde approach through a bone and through the osteochondral defect,and delivering a stratiform osteochondral graft, including a bone graftmaterial and a tissue graft material, to the perimeter through thetunnel using the retrograde approach such that a surface of the tissuegraft material closely matches the local cartilage topography or thelocal subchondral bone topography.

The bone graft material may be selected from the group consisting ofautograft bone, allograft bone, xenograft bone, demineralized bonematrix, bone graft substitutes, extracellular matrix, bone cells, growthfactors, blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof.

The tissue graft material may be selected from the group consisting ofautograft cartilage, allograft cartilage, xenograft cartilage,extracellular matrix, tissue scaffolds, cartilage cells, cell sheets,biological glues, growth factors, blood derivatives, bone marrowaspirate, synthetic cartilage, and combinations thereof.

The method may further include, prior to delivering the stratiformosteochondral graft to the perimeter, fabricating the stratiformosteochondral graft by shaping the stratiform osteochondral graft suchthat, with the stratiform osteochondral graft in the tunnel, the surfaceis positionable to match the local cartilage topography or the localsubchondral bone topography.

Fabricating the stratiform osteochondral graft may further includeshaping the bone graft material such that a surface of the bone graftmaterial closely matches the local cartilage topography or the localsubchondral bone topography.

Determining the local cartilage topography or the local subchondral bonetopography may include inserting a trial into the tunnel, the trialhaving a distal surface, advancing the trial through the tunnel untilthe distal surface aligns with the local cartilage topography or thelocal subchondral bone topography, and confirming that the distalsurface is shaped to match the local cartilage topography or the localsubchondral bone topography.

Determining the local subchondral bone topography may include insertinga trial into the tunnel, the trial having a distal edge around thedistal surface, advancing the trial through the tunnel until the distaledge of the distal surface aligns with the circumferential edge of thesubchondral bone, which is in intimate contact with the circumferentialedge of the cartilage, and confirming that the distal edge is shaped tomatch the local subchondral bone topography.

The trial may have a trial shaft and a trial tip with the distalsurface. The method may further include, prior to inserting the trialinto the tunnel, selecting the trial tip from a plurality of trial tipsthat are matable with the trial shaft. The plurality of trial tips mayinclude a plurality of distal surfaces of different shapes and/ororientations. The method may further include mating the trial tip to thetrial shaft.

Fabricating the stratiform osteochondral graft may include shaping thetissue graft material to match the distal surface of the trial.

Fabricating the stratiform osteochondral graft may include compressingthe bone graft material and/or the tissue graft material in a deliverytube. Delivering the stratiform osteochondral graft to the perimeter mayinclude connecting the delivery tube, containing the stratiformosteochondral graft, to the tunnel, and moving the stratiformosteochondral graft out of the delivery tube and into the tunnel.

The method may further include attaching a bone port proximal end and/ora bone port distal end of a bone port to the bone. Delivering thestratiform osteochondral graft to the perimeter may include insertingthe stratiform osteochondral graft through the bone port.

According to some embodiments, a method of fabricating a stratiformosteochondral graft to treat an osteochondral defect may includedetermining a local cartilage topography or a local subchondral bonetopography surrounding a perimeter of the osteochondral defect, shapinga bone graft material, positioning a tissue graft material adjacent tothe bone graft material, and causing a surface of the tissue graftmaterial to match the local cartilage topography or the localsubchondral bone topography.

The bone graft material may be selected from a group consisting ofautograft bone, allograft bone, xenograft bone, demineralized bonematrix, bone graft substitutes, extracellular matrix, bone cells, growthfactors, blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof.

The tissue graft material may be selected from a group consisting ofautograft cartilage, allograft cartilage, xenograft cartilage,extracellular matrix, tissue scaffolds, cartilage cells, cell sheets,biological glues, growth factors, blood derivatives, bone marrowaspirate, synthetic cartilage, or combinations thereof.

Shaping the bone graft material may include causing a surface of thebone graft material to match the local cartilage topography or the localsubchondral bone topography.

Shaping the bone graft material may include compressing the bone graftmaterial with a first compression force. Causing the surface of thetissue graft material to match the local cartilage topography or thelocal subchondral bone topography may include compressing the tissuegraft material with second compression force. The first compressionforce may be higher than the second compression force.

Causing the surface of the tissue graft material to match the localcartilage topography or the local subchondral bone topography mayinclude causing a bone graft material surface of the bone graft materialto match the local subchondral bone topography, and causing a tissuegraft material surface of the tissue graft material to match the localcartilage topography.

According to some embodiments, a method of delivering a stratiformosteochondral graft to a bone tunnel in a bone may include attaching abone port proximal end and/or a bone port distal end of a bone port tothe bone, attaching a delivery tube distal end of a delivery tube to thebone port proximal end, the delivery tube containing a stratiformosteochondral graft, and delivering the stratiform osteochondral graftto the bone tunnel from the delivery tube through the bone port.

The method may further include, after delivering the stratiformosteochondral graft to the bone tunnel, moving the stratiformosteochondral graft through the bone tunnel such that a surface of thestratiform osteochondral graft matches a local cartilage topography or alocal subchondral bone topography surrounding an internal opening of thebone tunnel.

The method may further include, prior to delivering the stratiformosteochondral graft to the bone tunnel, fabricating the stratiformosteochondral graft by shaping the stratiform osteochondral graft suchthat, with the stratiform osteochondral graft in the bone tunnel, thesurface is positionable to match the local cartilage topography or thelocal subchondral bone

The stratiform osteochondral graft may further include of a bone graftmaterial and a tissue graft material.

The bone graft material may be selected from a group consisting ofautograft bone, allograft bone, xenograft bone, demineralized bonematrix, bone graft substitutes, extracellular matrix, bone cells, growthfactors, blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof.

The tissue graft material may be selected from a group consisting ofautograft cartilage, allograft cartilage, xenograft cartilage,extracellular matrix, tissue scaffolds, cartilage cells, cell sheets,biological glues, growth factors, blood derivatives, bone marrowaspirate, synthetic cartilage, or combinations thereof.

These and other features and advantages of the present disclosure willbecome more fully apparent from the following description and appendedclaims or may be learned by the practice of the devices, systems, andmethods set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the present disclosure will become more fullyapparent from the following description taken in conjunction with theaccompanying drawings. Understanding that these drawings depict onlyexemplary embodiments and are, therefore, not to be considered limitingof the scope of the present disclosure, the exemplary embodiments of thepresent disclosure will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a perspective view of a reusable kit of instruments for tissueharvesting and delivery, according to one embodiment.

FIG. 2 is an exploded view of a subset of the instruments shown in FIG.1 for a select tissue tunnel size that have shared interconnectionfeatures.

FIG. 3 is a perspective view of a single use kit of instruments thatcomplement the subset of instruments shown in FIG. 1 to facilitate asurgical procedure for a select tissue tunnel size.

FIG. 4 is a perspective view from a lateral viewpoint of a proximaltibia and a guidewire placed into the tibia and into an osteochondrallesion from a retrograde approach.

FIG. 5A is a perspective view from a lateral viewpoint of the proximaltibia shown in partial cross section and a trephine placed over theguidewire and into the proximal tibia and through the cartilage from aretrograde approach.

FIG. 5B is a perspective view from a lateral viewpoint of the proximaltibia shown in partial cross section and an obturator placed over theguidewire and a bone port placed over the obturator and into theproximal tibia.

FIG. 6 is a perspective view from a lateral viewpoint of the proximaltibia shown in partial cross section and a trephine inside of a boneport, and the bone port secured to the tibia.

FIG. 7 is the view of FIG. 6 with the trephine removed and a capattached to a bone port.

FIG. 8A is a perspective view from a lateral viewpoint of the proximaltibia shown in partial cross section and a trial shaft with an attachedangled trial tip placed through a bone portal and with the trial tipdistal end positioned to match the surface topography of the surroundingcartilage.

FIG. 8B is a perspective view from a lateral viewpoint of the proximaltibia shown in partial cross section and a trial shaft with an attachedangled trial tip placed through a bone portal and with the trial tipdistal end positioned to match the surface topography of the surroundingcartilage.

FIG. 9A is a perspective view showing a base next to an angled trial tipconnected to a trial shaft.

FIG. 9B is the view of FIG. 9A showing the transfer of an angled trialtip from a trial shaft to a base.

FIG. 10A is a perspective view showing a delivery tube attached to abase with an assembled angled trial tip positioned in the delivery tubewith a tamp inserted into the proximal end.

FIG. 10B is a close-up view of FIG. 10A with the delivery tube cut awayto show bone graft material compacted proximally by a trial and distallyby the angled trial tip.

FIG. 11 is a perspective view in partial cross-section showing cartilagegraft material compacted into the distal end of the delivery tubedistally by an angled trial tip to fabricate a stratiform osteochondralgraft.

FIG. 12 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia showing a loaded delivery tubeengaged with a bone port.

FIG. 13 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia shown with a tamp pushing thestratiform osteochondral graft into final position.

FIG. 14 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia with a bone port secured to theproximal tibia, an enlarged bone defect site located in the proximaltibia, and a funnel attached to the bone port.

FIG. 15 is the view of FIG. 14 showing rotation and pushing of a trialto displace bone graft material into the enlarged bone defect site.

FIG. 16 is the view of FIG. 15 showing a delivery tube loaded withcompacted bone graft material, with the delivery tube attached to thebone port.

FIG. 17 is the view of FIG. 16 showing a tamp pushing the compacted bonegraft into final position.

FIG. 18 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia with an obturator inserted into anexisting bone tunnel, and a bone port placed over the obturator.

FIG. 19 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia with the bone port secured to thetibia, a delivery tube attached to the bone port, with the delivery tubeloaded with compacted bone graft material.

FIG. 20 is the view of FIG. 19 showing a tamp pushing the compacted bonegraft material into final position.

FIG. 21 is a flow chart showing a method of treating an osteochondraldefect, according to one embodiment.

FIG. 22 is a flow chart showing a method of fabricating a stratiformosteochondral graft, according to one embodiment.

FIG. 23 is a flow chart showing a method of treating a bone defect,according to one embodiment.

FIG. 24 is a flow chart showing a method of treating an existing bonetunnel, according to one embodiment.

It is to be understood that the drawings are for purposes ofillustrating the concepts of the present disclosure and may not be drawnto scale. Furthermore, the drawings illustrate exemplary embodiments anddo not represent limitations to the scope of the present disclosure.

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understoodby reference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the present disclosure, as generally described and illustrated in thedrawings, could be arranged, and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the implants, systems, and methods, as represented in thedrawings, is not intended to limit the scope of the present disclosure,but is merely representative of exemplary embodiments of the presentdisclosure.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in the drawings, the drawings are notnecessarily drawn to scale unless specifically indicated.

The following examples have been included to provide guidance to one ofordinary skill in the art for practicing representative embodiments ofthe presently disclosed subject matter. In light of the presentdisclosure and the general level of skill in the art, those of skill inthe art can appreciate that the following examples are intended to beexemplary only and that numerous changes, modifications, and alterationscan be employed without departing from the scope of the presentlydisclosed subject matter.

For purposes of interpreting this specification, the followingdefinitions will apply. If any definition set forth below conflicts withany document incorporated herein by reference, the definition set forthbelow shall control.

Bone and cartilage, collectively, are referred to as tissue herein.Bone-cartilage defect, osteochondral defect and osteochondral lesion aresynonymous, and generally referred to herein as a lesion. Bone marrowedema, focal osteolysis and a bone cyst are generally referred to hereinas a bone defect. Proximal means closer to a user, distal means fartheraway from a user. For example, the handle of a screwdriver is on aproximal end, and the drive tip of a screwdriver is on a distal end.

FIG. 1 is a perspective view of a reusable kit of instruments, or system100, for tissue harvesting and delivery. The system 100 may include aguidewire 110, a plurality of trephines 120, a plurality of bone ports130, a plurality of tamps 140, and a plurality of obturators 150. Thetrephines 120, bone ports 130, tamps 140, and obturators 150 are eachshown in 5 sizes, ranging from 6 mm to 14 mm in 2 mm increments, wherethe size is the size of the tissue tunnel to be formed by the selectedsubset of the system 100. Other sizes and other increments are possible,for example, ranging from 4 mm to 20 mm in 1 mm increments.

FIG. 2 is an exploded view of a subset 200 of the instruments of thesystem 100 of FIG. 1 for a select tissue tunnel size that have sharedinterconnection features. The subset 200 includes the guidewire 110, atrephine 220, a bone port 230, a tamp 240, and an obturator 250. Theselect tunnel size in this case is 10 mm, or the middle size in therange of sizes in the system 100 of FIG. 1 .

The guidewire 110 may be a surgical guide wire of any known type, suchas a K-wire or Steinmann Pin. The guidewire 110 may have a guidewireouter diameter 112.

The trephine 220 may have a trephine proximal end 222, a trephine distalend 224, a trephine longitudinal axis 225 extending between the trephineproximal end 222 and the trephine distal end 224, a drive shaft 226located near the trephine proximal end 222, and a drive shaftcannulation 227 extending along the trephine longitudinal axis 225. Theguidewire outer diameter 112 may be sized to closely fit inside thedrive shaft cannulation 227, optionally with some clearance so that thetrephine 220 can slide along the guidewire 110. Approaching the trephinedistal end 224, the trephine 220 may have an osteochondral cutter 228terminating in a set of teeth 229 configured to cut tissue as thetrephine 220 is rotated and pressed against tissue, forming a tunnel.The osteochondral cutter 228 may have a trephine outer diameter 223. Thetrephine 220 is just one of many different types of rotary cutters thatmay be used to cut tissue according to the present disclosure. Inalternative embodiments, different rotary cutters, such as drills,reamers, and/or augers, may be used in addition to or in place of thetrephine 220. The term “rotary cutter” encompasses all of thesealternatives in addition to a trephine.

The bone port 230 may have a bone port proximal end 232, a bone portdistal end 234, a bone port longitudinal axis 235 extending between thebone port proximal end 232 and bone port distal end 234, and a bone portcannulation 237. The bone port cannulation 237 may have a bone portinner diameter 233 sized to closely fit over the outer diameter of theosteochondral cutter 228 so that the bone port longitudinal axis 235 andthe trephine longitudinal axis 225 are coaxial when the bone port 230and the trephine 220 are engaged. Further, the bone port 230 may have apin aperture 238 and a series of orientation markings 239 proximate thebone port proximal end 232. Teeth 231 on the bone port distal end 234may help anchor the bone port 230 to bone when tapped or drilled intoplace.

The tamp 240 may have a tamp proximal end 242, tamp distal end 244, anda tamp outer diameter 246. The tamp proximal end 242 may have a handle247 that is designed to be pressed by hand and/or impacted with a malletor other instrument to compress graft material at the tamp distal end244. A series of depth markings, such as circumferential grooves 249,may be arranged along the length of the proximal portion of the tamp240, and may help the user gauge the motion travelled by the tamp 240 inthe course of compacting tissue material, and thence, the degree ofcompaction applied by the tamp 240 to the tissue material. Additionally,the tamp distal end 244 may be used to move graft material from oneposition to another.

The obturator 250 may have an obturator proximal end 252, an obturatordistal end 254, and an obturator outer diameter 256, which may besubstantially equal to the trephine outer diameter 223, the bone portinner diameter 233, and the tamp outer diameter 246. The obturatordistal end 254 may be tapered to facilitate insertion of the obturator250 into an opening tissue, such as a pre-existing bone tunnel, in orderto widen and/or prepare the opening for further steps.

The guidewire 110, the trephine 220, the bone port 230, the tamp 240,and/or the obturator 250 may be designed for reuse. Thus, thesecomponents may be formed of durable and readily sterilizable, andre-sterilizable, materials, such as stainless steel, or any othermaterial known for use in the manufacture of surgical instruments. Inalternative embodiments, one or more of these components may be designedfor single use, and may thus be formed of less durable materials, suchas plastics, if desired. In the present embodiment, the components ofthe system 100 may be designed for use with a system 300 of single usecomponents. The system 100 and the system 300 may combine to define asystem with reusable components (from the system 100) and disposablecomponents (from the system 300). In some embodiments, the components ofthe system 100 may be sterilized and provided in a reusable assemblysuch as a re-sterilizable instrument tray. The components of the system300 may also be sterilized, but may be provided in disposable,single-use packaging, such as one or more sealed plastic packages. Thecomponents of the system 300 may be formed of less expensive lessdurable materials, such as plastic materials, if desired. Alternatively,some or all of the components of the system 300 may be formed of durablere-sterilizable materials and added to the reusable instrument trayand/or provided separately.

FIG. 3 is a perspective view of the system 300, which may be a singleuse kit of instruments that complements the system 100 shown in FIG. 1to facilitate a surgical procedure for the select tissue tunnel size of10 mm. Separate systems may be provided for each size tissue tunnel thatis desired for treatment. For example, in addition to the system 300,additional systems (not shown) may be provided along with the system 100to facilitate treatment using 6 mm, 8 mm, 12 mm, and 14 mm tissuetunnels. The system 300 may include a fixation pin 310, a plurality oftrial tips 320, a base 330, a cap 340, a delivery tube 350, a funnel360, and a trial shaft 370.

Like the guidewire 110, the fixation pin 310 may be any type of bone pinknown in the art. For example, the fixation pin 310 may be a k-wire orthe like. The fixation pin 310 may be sized to slide into the pinaperture 238 of the bone port 230, and may fit sufficiently tightlywithin the pin aperture 238 such that the bone port 230 is maintained ata constant relative orientation by engagement of the pin aperture 238with the guidewire 310.

Each of the trial tips 320 may have a trial tip proximal end 322, atrial tip distal end 324, and a trial tip outer diameter 326. Each ofthe trial tips 320 may further have an attachment feature, such as aslot 327, that facilitates attachment to the base 330 and/or the trialshaft 370. Thus, each of the trial tips 320 may be interchangeablyattachable to the same male attachment feature.

Each trial tip distal end 324 may be planar, but the orientation of thetrial tip distal end 324 may vary among the trial tips 320. Theorientation of the trial tip distal end 324 may range, among the trialtips, 320, from 0° to 50°, measured as the offset from a planeperpendicular to the axis extending from the trial tip proximal end 322to the trial tip distal end 324. Each of the trial tips 320 may have anangle indicator 329 that indicates the orientation of the trial tipdistal end 324.

In alternative embodiments, different increments may be used; suchincrements may be greater than or smaller than 5° (for example, 1°, 2°,3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 12.5°, 15°, 20°, 22.5°, or 25°).Further, the orientation of the trial tip distal end 324 need not have amaximum of 50°; a smaller or greater maximum orientation may be used(for example, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°,75°, or 80°). In some embodiments, where it is desired to approach anosteochondral defect from an orientation nearly parallel to thecartilage surface, the maximum orientation may approach 90°.

In alternative embodiments, the trial tip distal end 324 of the trialtips 320 may have any range of unique shapes, including concave, convex,or even more complex shapes. Additionally or alternatively, the trialtip distal end 324 of each of the trial tips 320 may be shaped to matcha specific cartilage topography for a specific osteochondral defect fora specific patient. For trial tip distal ends that are not planar, twotrial tips with complementary shapes (not shown) may be used for aspecific osteochondral defect. The first trial tip may directlycorrespond to a cartilage surface when it is used as a trial as shown inFIG. 8A and FIG. 8B, and the second trial tip may correspond to thenegative (i.e., a Boolean subtraction) of the cartilage surface when itis used to compact bone graft material and cartilage graft material asshown in FIG. 10B and FIG. 11 .

The base 330 may have a body 332, a plateau 334, and an attachmentfeature configured to mate with the slot 327 of the trial tips 320, suchas a slider 337. The body 332 may have an enlarged shape that can bereadily grasped by a user and/or placed on a flat surface during use.The plateau 334 may have a width similar in size to that of the deliverytube 350. The plateau 334 and/or the slider 337 may optionally beincorporated into an insert, separate from the body 332, that can beassembled with the body 332 (for example, via insertion of the insertinto a hole in the body 332) to provide the assembled configurationshown in FIG. 3 .

The cap 340 may be sized to fit over the bone port proximal end 232and/or the delivery tube proximal end 352. Thus, the cap 340 may have abore 344 with an interior diameter (not shown) that is close to theouter diameter of the bone port proximal end 232 and the delivery tubeproximal end 352. The cap 340 may further have a cap port 346 thatprovides a leak resistant seal. The cap port 346 may be flexible andself-closing, so that instruments can be passed through the cap port 346and still maintain a leak resistant seal. The cap 340 may be formed of aresilient, flexible material, such as rubber, to help provide a sealbetween the cap 340 and the bone port proximal end 232 and/or thedelivery tube proximal end 352, and the seal provided by the cap port346.

The delivery tube 350 may have a delivery tube proximal end 352, adelivery tube distal end 354, and a delivery tube longitudinal axis 355extending between the delivery tube proximal end 352 and delivery tubedistal end 354. The delivery tube distal end 354 may be sized to closelyfit into the bone port proximal end 232 so that the delivery tubelongitudinal axis 355 and the bone port longitudinal axis 235 arecoaxial when the delivery tube 350 and the bone port 230 are coupledtogether.

The funnel 360 may have a funnel proximal end 362, a funnel distal end364, a funnel longitudinal axis 365 extending between the funnelproximal end 362 and funnel distal end 364. The funnel distal end 364may be sized to closely fit into the bone port proximal end 232 and/orthe delivery tube proximal end 352 and/or delivery tube distal end 354,so that the funnel longitudinal axis 365 is coaxial with the bone portlongitudinal axis 235 or the delivery tube longitudinal axis 355,respectively. The funnel proximal end 362 may have a flared shapeconfigured to facilitate insertion of graft material and instrumentsinto the funnel 360, and thence into the bone port 230 and/or deliverytube 350.

The trial shaft 370 may have a trial shaft proximal end 372, a trialshaft distal end 374, and a trial shaft outer diameter 376, which may besubstantially equal to the trephine outer diameter 223, the bone portinner diameter 233, and the tamp outer diameter 246. The trial shaftdistal end 374 may have an attachment feature, such as a slider 377,that is designed to mate with the slot 327 of each of the trial tips320. The slider 377 may have an enlarged tip and the slot 327 may have acomplementary shape so that, when coupled to each other, each of thetrial tips 320 cannot be pulled distally away from the trial shaft 370.The trial shaft 370 may further have a handle 378 at the trial shaftproximal end 372, and a series of depth markings 379 between the trialshaft proximal end 372 and the trial shaft distal end 374.

The assembled trial shaft 370 and one of the trial tips 320 are referredto as a trial, which may have an outer diameter substantially equal tothe tamp outer diameter 246. To accommodate the select tunnel size of 10mm, the trephine outer diameter 223 of the osteochondral cutter 228, theinner diameter of the bone port cannulation 237, the tamp outer diameter246, and the trephine outer diameter 223 may all be nominally 10 mm insize. Those of skill in the art will recognize that some variation fromthe nominal size may be desirable; for example, the inner diameter ofthe bone port cannulation 237 may be slightly larger than the trephineouter diameter 223, the trial tip outer diameter 326, and the trialshaft outer diameter 376 so that the trephine 220, each of the trialtips 320, and/or the trial shaft 370 may be inserted and relativelyfreely slide into the bone port cannulation 237 of the bone port 230.

While the mating connections between bone port 230, delivery tube 350,funnel 360, and cap 340 are shown with specific male and femalearrangements, in alternative embodiments (not shown), the connectionscan be easily reversed and still preserve the coaxial relationshipbetween respective longitudinal axes required to ensure proper function.Further, many different mating and non-mating connections may be used,including but not limited to clips, claps, mechanical fasteners, bayonetfittings, and/or the like.

The system 100 and/or the system 300 may be used to help repairosteochondral defects in bone. In some embodiments, this may beaccomplished by (1) harvesting tissue, (2) preparing the harvestedtissue, and (3) placing the prepared tissue at the defect site. Notably,this approach assumes that the tissue is natural (i.e., autograft,allograft, or even xenograft). However, the system 100 and/or the system300 may also be used with synthetic graft or bone graft substitutes; insuch cases, (1) and/or (2) above may not be needed.

In some embodiments, the process of harvesting the tissue may be formedas part of the process of removing the osteochondral defect and/orpreparing the defect site for repair. Healthy tissue at or around therepair site may be removed, prepared, and inserted back into the repairsite, optionally with additional natural or synthetic tissue. FIGS. 4through 8 illustrate the process of harvesting tissue and preparing adefect site for repair (i.e., step (1) in the preceding paragraph)according to one embodiment.

FIG. 4 is a perspective view from a lateral viewpoint of a proximaltibia 400 with the guidewire 110 placed into the proximal tibia 400 andinto the central aspect of an osteochondral lesion 410 from a retrogradeapproach (i.e., through the tissue beneath the osteochondral lesion410). The placement of the guidewire 110 into the bone and cartilage canbe accomplished using a powered pin driver (not shown), and theguidewire 110 can be placed manually or using a targeting drill guide(not shown) known in the art. Fluoroscopy and/or other medical imagingmay be used to guide placement of the guidewire 110. In someembodiments, direction visualization (for example, via arthroscopiccameras inserted into the knee joint) may be used to guide and/orconfirm placement of the guidewire 110.

The proximal tibia 400 is used in the figures is for illustrativepurposes. The systems and methods of the present disclosure may be usedto treat any bone and/or cartilage location in the body. Cartilage isfound in all the articular joints of the body. In the example of FIG. 4, the osteochondral lesion 410 is located in the knee joint. Otherarticular joints in the body that may be treated with the systems andmethods presented herein include, but are not limited to: ametatarsal-phalangeal joint, a metatarsal-tarsal joint, a tarsal-tarsaljoint, a subtalar joint, a calcaneal-tarsal joint, an ankle joint, a hipjoint, a metacarpal-phalangeal joint, a metacarpal-carpal joint, acarpal-carpal joint, a wrist joint, an elbow joint, a shoulder joint,and spine facet joint.

FIG. 5A is a perspective view from a lateral viewpoint of the proximaltibia 400 shown in partial cross section and the trephine 220 placed andslid over the guidewire 110 and into the proximal tibia 400 and throughthe osteochondral lesion 410 from a retrograde approach, forming atissue tunnel 500 underneath the repair site. The drive shaftcannulation 227 may fit closely over the guidewire 110 such that thetrephine 220 tracks precisely to the osteochondral lesion 410. In analternative embodiment, a cannulated drill or other cannulated cutterknown in the art (not shown) may be used in place of or in addition tothe trephine 220 to form the tissue tunnel 500. The tissue tunnel 500may extend sufficiently far to include the osteochondral lesion 410. Inthis application, the term “tissue tunnel” is intended to cover tunnelsthrough various types of tissue, including but not limited to tunnelsthrough bone, cartilage, and combinations of bone and cartilage.

In this example, the tissue tunnel 500 may be approximately 10 mm insize because the trephine outer diameter 223 of the osteochondral cutter228 may be about 10 mm. Any of the trephines 120 of FIG. 1 may be usedto provide a tissue tunnel of the appropriate size for a particularjoint and/or a particular osteochondral defect.

FIG. 5B is a perspective view from a lateral viewpoint of the proximaltibia 400 shown in partial cross section and an obturator 250 placedover the guidewire 110 and a bone port 230 placed over the obturator 250and into the proximal tibia 400. The obturator 250 may be used tofacilitate placement of the bone port 230 such that the bone portcannulation 237 is coaxial with the tissue tunnel 500 (not shown).

FIG. 6 is the view of FIG. 5A with the bone port 230 placed and slidover the trephine 220 and secured to the proximal tibia 400. FIG. 6 isalso the view of FIG. 5B with bone port 230 used to guide the trephine220 into the formation of tissue tunnel 500. The bone port innerdiameter 233 may closely fit over the trephine outer diameter 223 toensure that the bone port longitudinal axis 235 and the trephinelongitudinal axis 225 are coaxial, irrespective of which is placedfirst. The teeth 231 on the bone port distal end 234 may be serrated andmay allow the bone port distal end 234 to be inserted along the boneport longitudinal axis 235 into the bone, thereby securing the bone port230 to the bone. Alternatively, or in combination with securing of thebone port distal end 234 to the bone, the bone port 230 can be securedto bone adjacent to the bone port proximal end 232. For example, the pinaperture 238 may receive the fixation pin 310 to secure the bone port230 to the bone.

Notably, the bone port 230 need not necessarily be used to dilate orretract tissue; rather, these steps may be performed with otherinstruments, such as the obturator 250, prior to application of thetrephine 220. The trephine 220 may guide placement of the bone port 230as the bone port 230 may be slid into position over the trephine 220, orthe bone port 230 may guide placement of the trephine 220. Formation ofthe tissue tunnel 500 with the trephine 220 prior to attachment of thebone port 230 may facilitate and/or enable the bone port 230 to be usedfor other functions besides guiding the trephine 220. For example, thebone port 230 may maintain retraction of the surrounding soft tissuesuch as muscle, fat and skin (not shown). This may be advantageous forsubsequent operative steps, such as visualizing the interior of thetissue tunnel 500 with an endoscope (not shown), removing additionaltissue from the interior of the tissue tunnel 500, accessing anintra-articular space, and/or delivering bone graft materials and/orcartilage graft materials to the repair site through the tissue tunnel500.

FIG. 7 is the view of FIG. 6 with the trephine 220 removed. With thetrephine 220 removed, a user may attach the cap 340 to the bone portproximal end 232 to form a leak resistant seal to facilitate theperformance of an arthroscopic procedure in the knee joint space. Thecap port 346 may provide another leak resistant seal when instrumentsare passed through the cap port 346. For example, the user can insert anendoscope (not shown) through the cap port 346 and into the tissuetunnel 500 to allow for direct visualization of the cartilage layer andunderlying bone to ensure that all the damaged/diseased cartilage and/orbone associated with the osteochondral lesion 410 have been removed. Ifdamaged/diseased cartilage and/or bone remain, then the user can pass acurette or other cutting instrument (not shown) to excavate theremaining damaged/diseased tissue.

Loose tissue may be removed from the tissue tunnel 500. Much of theloose tissue may come out of the tissue tunnel 500 with the removal oftrephine 220. Additional instruments, suction, and/or the like may beused to remove any remaining pieces of bone or cartilage from the tissuetunnel 500.

FIG. 8A is a perspective view from a lateral viewpoint of the proximaltibia 400 shown in partial cross section, with the trial shaft 370 and atrial tip 800, attached to the trial shaft 370, placed through the boneport 230. The trial tip 800 may be one of the trial tips 320, angled at45°. As shown, the trial tip 800 may be positioned and oriented suchthat the trial tip distal end 324 is positioned to match the surfacetopography of the surrounding cartilage and/or bone around the repairsite. The trial shaft outer diameter 376 may be approximately 10 mm toprovide for a close sliding fit inside the bone port inner diameter 233.The trial shaft 370 with an attached trial tip such as the trial tip 800is also referred to herein as a “trial.”

The trial tip 800 shown in FIG. 8 has a surface 810 on the trial tipdistal end 324 that is a plane at a 45-degree angle to the bone portlongitudinal axis 235. Users can select from a plurality of trial tips(for example, from the trial tips 320 of FIG. 3 ) to find the trial tipwith a trial tip distal end that is most conformal to the topography ofthe surrounding cartilage and/or bone. Some trial and error may beneeded. In addition to the depth markings 379, the trial shaft 370and/or the trial tip 800 have one or more trial timing marks 820 thatare used to indicate the circumferential orientation of the trialrelative to the bone port 230 as measured against the one or morecircumferential timing marks, such as the orientation markings 239 ofthe bone port 230. As shown in FIG. 8 , the circumferential orientationis approximately 55 degrees.

The depth markings 379 of the trial shaft 370 may be measured againstthe bone port proximal end 232 to indicate the depth that the trial tip800 extends beyond the entry hole into the tissue tunnel 500, thusallowing measurement of the length of the tissue tunnel 500 when thetrial tip distal end 324 is flush with the surrounding cartilagesurface. As shown in FIG. 8A, the length of the tissue tunnel 500 isapproximately 35 mm. The circumferential orientation and the length maybe noted by the user in preparation for future steps.

FIG. 8B is a perspective view from a lateral viewpoint of the proximaltibia 400 shown in partial cross section and a trial shaft 370 with anattached angled trial tip 800 placed through a bone port 230 and withthe trial tip distal end 324 positioned to match the surface topographyof the surrounding cartilage and/or bone. An optional orientationstorage feature may be coupled to the bone port proximal end 232 andused to record the orientation of the trial tip 800 when aligned withthe surrounding cartilage.

More precisely, the orientation storage feature may include a dial 850with a generally annular shape that can be rotatably coupled to the boneport proximal end 232. The dial 850 may have a pointer 852 that can bealigned, via rotation of the dial 850 on the bone port 230, with thetrial timing mark 820 of the trial shaft 370. When the trial shaft 370and the trial tip 800 are removed from the bone port 230, the dial 850may remain in place to facilitate alignment of the bone graft with thesurrounding cartilage, in a manner that matches the alignment of thetrial tip 800 with the surrounding cartilage.

The dial 850 is an optional feature. It may be used in place of, or inaddition to, the orientation markings 239 of the bone port 230. In someembodiments, the dial 850 may be aligned with the trial timing mark 820as described above, and then partially removed so that the user can seewhich of the orientation markings 239 is aligned with the pointer 852.This orientation may then be recorded for future use without requiringfurther use of the dial 850.

After performance of the steps illustrated in FIG. 8A and/or FIG. 8B,removal of the damaged and/or diseased tissue from the proximal tibia400 may be complete. All information needed to prepare the replacementtissue may have been obtained. Thus, the user may proceed to prepare thereplacement tissue, as will be shown and described in connection withFIGS. 9A through 11 . Advantageously, the bone port 230 may remainattached to the tissue tunnel 500 during preparation of the replacementtissue to facilitate the subsequent insertion of the replacement tissueinto the graft site.

FIG. 9A is a perspective view showing the base 330 (with assembledinsert, if applicable) next to the trial tip 800 connected to the trialshaft 370. The base 330 may releasably attach to the trial tip proximalend 322 such that the trial tip distal end 324 faces away from the base330. The base 330 may also releasably attach to the delivery tube distalend 354, for example, at or around the plateau 334. The base 330 mayhave a base timing mark 900 that aligns with the trial timing mark 820on the trial tip 800 when the trial tip 800 is assembled to the base330.

FIG. 9B is the view of FIG. 9A showing the transfer of the trial tip 800from the trial shaft 370 to the base 330. The trial tip 800 mayreleasably connect to each of the trial shaft 370 and the base 330 bysliding the trial tip 800 in from the side of the trial shaft 370 andbase 330, respectively, such that the slot 327 receives the slider 377of the trial shaft 370 or the slider 337 of the base 330. However, anyother releasable connection feature that resists dislodgement during usemay be substituted for the slot 327, the slider 377, and the slider 337.

FIG. 10A is a perspective view showing the delivery tube 350 attached tothe base 330 with the tamp 240 positioned in the delivery tube 350. Thedelivery tube 350 has a delivery tube timing mark 1000 and a deliverytube depth scale 1010. The delivery tube depth scale 1010 and/or thecircumferential grooves 249 can be referenced to create a graft havingthe same length as the previously measured length of the tissue tunnel500. When assembled to the base 330, the delivery tube timing mark 1000and the trial timing mark 820 may be aligned with the base timing mark900. If desired, one of the circumferential grooves 249 may be replacedwith a reference line 1030 to show a preferred depth of insertion of thetamp 240.

FIG. 10B is a close-up view of FIG. 10A with the delivery tube 350 cutaway to show bone graft material compacted proximally by a tamp 240 anddistally by the trial tip 800 used to simulate repair of theosteochondral lesion 410 in FIG. 8 to form a formed end on the compactedbone graft 1020 corresponding to the trial tip distal end 324 of thetrial tip 800. High forces, typically generated by strikes from asurgical mallet, may be applied (for example, to the handle 247 of thetamp 240) to fully compact the bone graft material to form the compactedbone graft 1020.

FIG. 11 is a perspective view in partial cross-section of the trialshaft 370 and the delivery tube 350, showing cartilage graft material1100 compacted into the delivery tube distal end 354 distally by thetrial tip 800 with trial shaft 370 attached, thereby fabricating astratiform osteochondral graft 1110 with a formed end 1120, having thecartilage graft material 1100, that corresponds to the shape of thetrial tip distal end 324 of the trial tip 800. Alternatively, trial tip800 could be attached to base 330 (of FIGS. 9A through 10B) to shapecartilage graft material 1100. The trial timing mark 820 and thedelivery tube timing mark 1000 may be maintained in alignment during thecompaction process. The delivery tube timing mark 1000 and/or the depthmarkings 379 of the trial shaft 370 may again be used to ensure that thestratiform osteochondral graft 1110 has the appropriate length to matchthe length of the tissue tunnel 500.

Compaction may be performed under light force, typically generated byhand pressure, to avoid compromising the biological viability of thecartilage graft material 1100. The method of compacting the bone graftmaterial under high force (described above in connection with FIGS. 10Aand 10B) as a distinct and separate step from compacting the cartilagegraft material under low force is advantageous for fabricating thestratiform osteochondral graft 1110 that has sound structural propertiesand cohesiveness while preserving the biological viability of the moredelicate biological components of the cartilage graft material 1100.

It is advantageous to fabricate a stratiform osteochondral graft 1110from constituent graft materials for several reason. First, the useautograft or allograft osteochondral plugs can be avoided when desired.The former has risk of harvest site morbidity, and the latter has riskof availability, immunological reactions, and disease transmission.Furthermore, the stratiform osteochondral graft 1110 can be createdlayer by layer, allowing the selection of the graft material that hasthe highest potential to remodel and heal into the same tissueconstituency and structure as normal osteochondral tissue. For example,normal osteochondral tissue presents with the following distinctbiological zones: 1) a cartilage surface layer, where elongate cartilagecells are arranged with their long axes parallel to the surface, 2) acartilage transition layer, 3) a cartilage deep layer, where elongatecartilage cells are arranged with their long axes perpendicular to thesurface, 4) a demarcation layer called the tidemark, 5) a calcifiedcartilage layer, and 6) a subchondral bone layer. Optimal graftmaterials can be selected to optimally reproduce the biologicalconstituency and structure of each of these biological layers. A list ofgraft materials for cartilage and bone is provided below.

The bone graft material may be selected from a group consisting ofautograft bone, allograft bone, xenograft bone, demineralized bonematrix, bone graft substitutes, extracellular matrix, bone cells, growthfactors, blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof. Bone graft substitutes may be selected from agroup consisting of: tricalcium phosphates, hydroxyapatites, calciumphosphates, calcium sulfates, bioglasses, collagen, and combinationsthereof. Extra cellular matrix may be selected from a group consistingof proteoglycans (including heparan sulfate, chondroitin sulfate andkeratan sulfate), hyaluronic acid, collagen, elastin, fibronectin,laminin. Bone cells may be selected from the group consisting ofosteocytes, osteoblasts, mesenchymal stem cells, embryonic stem cells,and combinations thereof. Growth factors may be selected from a groupconsisting of transforming growth factor (TGF), bone morphogenic protein(BMP), insulin-like growth factor (IGF), vascular endothelial growthfactor (VEGF), platelet-derived growth factor (PDGF), fibroblast growthfactor (FGF), hepatocyte growth factor (HGF), and combinations thereof.Blood derivatives may be selected from a group consisting of wholeblood, platelet rich plasma, and combinations thereof.

Cartilage graft material may be selected from a group consisting ofautograft cartilage, allograft cartilage, xenograft cartilage,extracellular matrix, tissue scaffolds, cartilage cells, cell sheets,biological glues, growth factors, blood derivatives, bone marrowaspirate, synthetic cartilage, or combinations thereof. Cartilage cellsare selected from a group consisting of chondrocytes, chondroblasts,mesenchymal stem cells, embryonic stem cells, and combinations thereof.Biological glues are selected from a group consisting of fibrin glue,mussel glue, vitronectin, chondronectin, osteonectin, fibronectin,laminins, arginine-glycine-aspartic acid peptide, and combinationsthereof.

Notably, autograft materials may be harvested from other locations inthe body, besides the vicinity of the osteochondral lesion 410. Forexample, in some embodiments, a second tissue tunnel (not shown) may beformed through the proximal tibia 400 to obtain bone and/or cartilagefrom a different portion of the proximal tibia 400. Additionally oralternatively, tissue may be obtained from a different bone and/or jointthrough the use of the systems and methods set forth above.

Once the compaction process of FIG. 11 has been carried out, thestratiform osteochondral graft 1110 may be ready for placement in thegraft site. One manner in which this may be accomplished will be shownand described in connection with FIGS. 12 and 13 .

FIG. 12 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia 400, showing the delivery tube 350engaged with the bone port 230. The stratiform osteochondral graft 1110may have a graft proximal end 1200 and a graft distal end 1210. Thecompacted stratiform osteochondral graft 1110 may be positioned in thedelivery tube 350 such that the graft distal end 1210, with thecartilage graft material 1100, is oriented toward the graft site.

FIG. 13 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia 400, shown with tamp 240 pushing thegraft proximal end 1200 so that the graft distal end 1210 is alignedwith the cartilage surface 1300 at the graft site. The stratiformosteochondral graft 1110 may be moved toward the cartilage surface 1300until the cartilage graft material 1100 is flush with the cartilagesurface 1300. The bone graft 1020 may then occupy the tissue tunnel 500,proximal to the cartilage surface 1300, as shown.

Once the stratiform osteochondral graft 1110 has been positioned asshown in FIG. 13 , the tamp 240, the delivery tube 350, and the boneport 230 may be removed from the proximal tibia 400. The wound site maybe closed and allowed to heal. The stratiform osteochondral graft 1110may then integrate with the surrounding tissue. For example, thecartilage graft material 1100 may integrate with the cartilage surface1300, and the bone graft 1020 may integrate with the bone surroundingthe tissue tunnel 500. The instruments of the system 300 used in theprocedure may be disposed of. The instruments of the system 100 used inthe procedure may be re-sterilized and prepared for use in anotherprocedure.

In some procedures, defective tissue may be found outside the peripheryof the tissue tunnel 500. In some cases, the ideal retrograde approachmay not pass through all of the diseased or damaged tissue that needs tobe removed. In other cases, diseased or damaged tissue outside thetissue tunnel 500 may be located (for example, endoscopically) after thetissue tunnel 500 has been formed. Curettes and/or other instrumentsknown in the art may be inserted into the tissue tunnel 500, through thebone port 230 or directly without the bone port 230, and used to removedamaged tissue from the walls of the tissue tunnel 500. Further, inother embodiments, the systems and methods disclosed herein may be usedto repair bone defects below an articular surface. In any of the abovecases, the damaged tissue may be replaced with any of the materialslisted previously. One method for doing this will be shown and describedin connection with FIGS. 14 through 17 .

FIG. 14 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia 400 with the bone port 230 securedto the proximal tibia 400 to facilitate access to a tissue tunnel 1400.An enlarged bone defect site 1410 may be located adjacent to the tissuetunnel 1400. In FIG. 14 , the enlarged bone defect site 1410 may bebelow the articular surface of the proximal tibia 400; thus, the tissuetunnel 1400 may be a blind hole through the bone of the proximal tibia400, that stops short of the articular cartilage. The tissue tunnel 1400may be formed, the bone port 230 may be attached, and visualization ofthe tissue tunnel 1400 may be obtained substantially as set forthpreviously in the descriptions of FIGS. 4-7 .

The funnel 360 may be attached to the bone port 230 to facilitateinsertion of a tissue replacement material, such as bone graft material,into the enlarged bone defect site 1410. In particular, the funneldistal end 364 may be secured to the bone port proximal end 232 suchthat the funnel longitudinal axis 365 is coaxial with the bone portlongitudinal axis 235. The funnel proximal end 362 may be flared tofacilitate insertion of material into the funnel proximal end 362, andthence into the tissue tunnel 1400 through the funnel 360 and the boneport 230. Alternatively, a delivery tube 350 (as shown in FIG. 3 ) maybe used between the funnel 360 and the bone port 230.

FIG. 15 is the view of FIG. 14 showing rotation and pushing of a trialto displace bone graft material 1500 into the enlarged bone defect site1410. In this embodiment, the bone graft material 1500 may be a looseand/or uncompacted material. The trial may include the trial shaft 370and the trial tip 800 with a trial tip distal end 324 that is angled at45°.

The angulation of the trial tip distal end 324 may help the trial tip800 displace the bone graft material 1500 transverse to the axis of thetissue tunnel 1400, into the enlarged bone defect site 1410. Prior toplacement of the bone graft material 1500, the position of the enlargedbone defect site 1410 relative to the tissue tunnel 1400 may beassessed, for example, with medical imaging. The position may berecorded and the trial may be rotated to align the trial tip distal end324 with the enlarged bone defect site 1410, for example, by aligningthe trial timing marks 820 with the orientation markings 239 of the boneport 230. The funnel 360 is illustrated in FIG. 15 but is optional; ifdesired, the funnel 360 may be omitted to facilitate alignment of thetrial timing marks 820 with the orientation markings 239.

After the bone graft material 1500 has been inserted into the enlargedbone defect site 1410, the bone graft material 1500 may optionally befurther pressed into the enlarged bone defect site 1410. For example, adifferent selection from the trial tips 320 may be attached to the trialshaft 370 and advanced through the bone port 230 to further press thebone graft material 1500 into the enlarged bone defect site 1410.Alternatively a tamp 240 (as shown in FIG. 2 ) can be used.

FIG. 16 is the view of FIG. 15 showing a delivery tube 350 loaded withcompacted bone graft material 1600. The delivery tube 350 may beattached to the bone port 230 as in FIG. 12 . The compacted bone graftmaterial 1600 may optionally include only bone, rather than being astratiform graft, as only bone is to be replaced. The compacted bonegraft material 1600 may be formed as shown and described in connectionwith FIGS. 9A and 9B, but may be made with a cylindrical shape ratherthan having an angled distal surface. Thus, one of the trial tips 320with a trial tip distal end 324 having a perpendicular orientation and acircular shape may be attached to the base 330 in place of the trial tip800, and used in the compaction of the bone graft 1020 to form thecompacted bone graft material 1600 with the generally cylindrical shape.

FIG. 17 is the view of FIG. 16 showing tamp 240 pushing the compactedbone graft material 1600 into final position adjacent to the enlargedbone defect site 1410. The user may rely on the “feel” (i.e., resistanceto distal motion) to know when to stop pushing on the handle 247 of thetamp 240. Additionally or alternatively, medical imaging may be used toassess the location of the enlarged bone defect site 1410 relative tothe tissue tunnel 1400, and the depth markings (i.e., circumferentialgrooves 249) of the tamp 240 may be used to push the bone graft material1500 to the appropriate depth. Once in place, the compacted bone graftmaterial 1600 may help retain the bone graft material 1500 in place inthe enlarged bone defect site 1410, and may also fill and facilitatehealing of the tissue tunnel 1400.

In addition to use of the systems and methods of the present disclosureto address tissue defects, these systems and methods may also be used tofill tissue voids resulting from bone atrophy, other surgicalprocedures, or prior surgical procedures that did not address the tissuevoid. One example of this will be presented in connection with FIGS.18-20 .

FIG. 18 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia 400 with obturator 250 insertedthrough the bone port 230. The existing tissue tunnel 1800 may becreated by the user to facilitate an arthrodesis by placing compactedbone graft material across a joint, or it may be the result of a failedprior surgery, such as a tissue tunnel in a failed anterior cruciateligament reconstruction surgery. The existing tunnel 1800 may be in thebone only, or may go all the way through the cartilage, like tunnel 500in FIG. 7 . The existing tissue tunnel 1800 may be accessed, forexample, with the aid of the obturator 250, the bone port 230 may beattached, and visualization of the existing tissue tunnel 1800 may beobtained substantially as set forth previously in the descriptions ofFIGS. 4-7 . The obturator distal end 254 may be bullet shaped tofacilitate entry into the existing tissue tunnel 1800.

FIG. 19 is a perspective view from a lateral viewpoint shown in partialcross section of the proximal tibia 400 with the bone port 230 securedto the proximal tibia 400, the delivery tube 350 attached to the boneport 230, and the delivery tube loaded with compacted bone graftmaterial 1900. As in FIGS. 16 and 17 , the compacted bone graft material1900 may be formed, for example, as set forth in connection with FIGS.9A and 9B, and may have a generally cylindrical shape. In alternativeembodiments, the compacted bone graft material 1900 may be shapeddifferently to suit the shape of the portion of the existing tissuetunnel 1800 in which it is to reside.

FIG. 20 is the view of FIG. 19 showing tamp 240 pushing the compactedbone graft material 1900 into final position within the existing tissuetunnel 1800. The tamp 240 may be used to push the compacted bone graftmaterial 1900 distally until the compacted bone graft 1900 has reachedthe desired location within the existing tissue tunnel 1800, which maybe a blind end of the existing tissue tunnel 1800 as shown in FIG. 19 .

FIG. 21 is a flow chart showing a method 2100 of treating anosteochondral defect, according to one embodiment. The method 2100 maysummarize steps that are shown and described in greater detail in FIGS.4 through 13 , and in the accompanying descriptions above.

In a step 2110, a tissue tunnel may be created to circumscribe theosteochondral defect from a retrograde approach. The step 2110 mayinclude the procedures shown in FIGS. 4 through 7 .

In a step 2120, trialing may be performed to determine the localcartilage and/or bone topography. The step 2120 may include theprocedures shown in FIGS. 8A and 8B.

In a step 2130, a stratiform osteochondral graft may be fabricated. Thestep 2130 may include the procedures shown in FIGS. 9A through 11 .

In a step 2140, the stratiform osteochondral graft may be delivered intothe tissue tunnel. The step 2140 may include the procedures shown inFIGS. 12 and 13 .

FIG. 22 is a flow chart showing a method 2200 of fabricating astratiform osteochondral graft, according to one embodiment. The method2200 may be a more detailed version of the step 2130 of the method 2100,and may summarize steps that are shown and described in greater detailin FIGS. 9A through 11 , and in the accompanying descriptions above.

In a step 2210, bone graft material may be compacted so that the distalend of the bone graft material closely matches the local cartilageand/or bone topography. The step 2210 may include the procedures shownin FIGS. 9A through 10B.

In a step 2220, cartilage graft material may be compacted so that thedistal end of the cartilage graft material closely matches the localcartilage and/or bone topography. The step 2220 may include theprocedures shown in FIG. 11 .

FIG. 23 is a flow chart showing a method 2300 of treating a bone defect,according to one embodiment. The method 2300 may summarize steps thatare shown and described in greater detail in FIGS. 14 through 17 , andin the accompanying descriptions above. Steps from FIGS. 9A through 10Bmay also be included.

In a step 2310, a bone tunnel may be created to access a bone defect.The step 2310 may include the procedures shown in FIG. 14 .

In a step 2320, a bone defect Space adjacent to the bone tunnel may befilled with bone graft material. The step 2320 may include theprocedures shown in FIGS. 15 and 16 .

In a step 2330, bone graft material may be compacted, or a bone graftplug may be otherwise obtained. The step 2330 may include the proceduresshown in FIGS. 9A through 10B.

In a step 2340, the compacted bone graft material or the bone graft plugmay be delivered to the bone tunnel. The step 2340 may include theprocedures shown in FIG. 17 .

FIG. 24 is a flow chart showing a method 2400 of treating an existingbone tunnel, according to one embodiment. The method 2400 may summarizesteps that are shown and described in greater detail in FIGS. 18 through20 , and in the accompanying descriptions above. Steps from FIGS. 9Athrough 10B may also be included.

In a step 2410, an existing bone tunnel may be located with an obturatorand a bone port. The step 2410 may include the procedures shown in FIG.18 .

In a step 2420, bone graft material may be compacted, or a bone graftplug may be otherwise obtained. The step 2420 may include the proceduresshown in FIGS. 9A through 10B.

In a step 2430, the compacted bone graft material or the bone graft plugmay be delivered to the bone tunnel. The step 2430 may include theprocedures shown in FIGS. 19 and 20 .

The method 2100, the method 2200, the method 2300, and the method 2400may utilize the system 100, the subset 200, and/or the system 300. Inthe alternative, the method 2100, the method 2200, the method 2300, andthe method 2400 may employ differently configured instruments. Likewise,the system 100, the subset 200, and/or the system 300 may be utilized inmethods different from the method 2100, the method 2200, the method2300, and the method 2400. Further, steps may be added to, omitted from,and/or replaced with alternatives in any of the method 2100, the method2200, the method 2300, and the method 2400, as would be envisioned by aperson skilled in the art.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the present disclosure. This method of disclosure, however,is not to be interpreted as reflecting an intention that any embodimentrequires more features than those expressly recited in that embodiment.Rather, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment.

As used herein, the term “proximal” means a location relatively closerto a user (i.e., a surgeon) when the user is installing the implant. Theterm “distal” means a location relatively further from the user. Forexample, when a user installs a bone screw into a material with adriver, the end of the bone screw engaged with the driver is theproximal end, and the tip of the bone screw that first engages thematerial is the distal end. The term “cannulated” means having a centralbore extending along a longitudinal axis of a part between a proximalend and a distal end of the part.

Recitation of the term “first” with respect to a feature or element doesnot necessarily imply the existence of a second or additional suchfeature or element. Elements recited in means-plus-function format areintended to be construed in accordance with 35 U.S.C. § 112(f). It willbe apparent to those having skill in the art that changes may be made tothe details of the above-described embodiments without departing fromthe underlying principles set forth herein.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other. The term“coupled” can include components that are coupled to each other viaintegral formation, as well as components that are removably and/ornon-removably coupled with each other. The term “abutting” refers toitems that may be in direct physical contact with each other, althoughthe items may not necessarily be attached together. The phrase “fluidcommunication” refers to two or more features that are connected suchthat a fluid within one feature is able to pass into another feature. Asdefined herein the term “substantially” means within +/−20% of a targetvalue, measurement, or desired characteristic.

While specific embodiments and applications of the present disclosurehave been illustrated and described, it is to be understood that thescope of this disclosure is not limited to the precise configuration andcomponents disclosed herein. Various modifications, changes, andvariations which will be apparent to those skilled in the art may bemade in the arrangement, operation, and details of the devices, systems,and methods disclosed herein.

What is claimed is:
 1. A method of treating an osteochondral defect, themethod comprising: determining a local cartilage topography or a localsubchondral bone topography surrounding a perimeter of an osteochondraldefect, wherein the perimeter is circumscribed by a tunnel with aretrograde approach through a bone and through the osteochondral defect;and delivering a stratiform osteochondral graft, comprising a bone graftmaterial and a tissue graft material, to the perimeter through thetunnel using the retrograde approach such that a surface of the tissuegraft material closely matches the local cartilage topography or thelocal subchondral bone topography.
 2. The method of claim 1, wherein thebone graft material is selected from the group consisting of autograftbone, allograft bone, xenograft bone, demineralized bone matrix, bonegraft substitutes, extracellular matrix, bone cells, growth factors,blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof.
 3. The method of claim 1, wherein the tissue graftmaterial is selected from the group consisting of autograft cartilage,allograft cartilage, xenograft cartilage, extracellular matrix, tissuescaffolds, cartilage cells, cell sheets, biological glues, growthfactors, blood derivatives, bone marrow aspirate, synthetic cartilage,and combinations thereof.
 4. The method of claim 1, further comprising,prior to delivering the stratiform osteochondral graft to the perimeter,fabricating the stratiform osteochondral graft by shaping the stratiformosteochondral graft such that, with the stratiform osteochondral graftin the tunnel, the surface is positionable to match the local cartilagetopography or the local subchondral bone topography.
 5. The method ofclaim 4, wherein fabricating the stratiform osteochondral graft furthercomprises shaping the bone graft material such that a surface of thebone graft material closely matches the local cartilage topography orthe local subchondral bone topography.
 6. The method of claim 1, whereindetermining the local cartilage topography or the local subchondral bonetopography comprises: inserting a trial into the tunnel, the trialcomprising a distal surface; advancing the trial through the tunneluntil the distal surface aligns with the local cartilage topography orthe local subchondral bone topography; and confirming that the distalsurface is shaped to match the local cartilage topography or the localsubchondral bone topography.
 7. The method of claim 6, wherein: thetrial comprises a trial shaft and a trial tip comprising the distalsurface; and the method comprises, prior to inserting the trial into thetunnel: selecting the trial tip from a plurality of trial tips that arematable with the trial shaft, wherein the plurality of trial tipscomprises a plurality of distal surfaces of different shapes and/ororientations; and mating the trial tip to the trial shaft.
 8. The methodof claim 6, wherein fabricating the stratiform osteochondral graftcomprises shaping the tissue graft material to match the distal surfaceof the trial.
 9. The method of claim 1, wherein: fabricating thestratiform osteochondral graft comprises compressing the bone graftmaterial and/or the tissue graft material in a delivery tube; anddelivering the stratiform osteochondral graft to the perimetercomprises: connecting the delivery tube, containing the stratiformosteochondral graft, to the tunnel; and moving the stratiformosteochondral graft out of the delivery tube and into the tunnel. 10.The method of claim 1, further comprising securing attaching a bone portproximal end and/or a bone port distal end of a bone port to the bone;wherein delivering the stratiform osteochondral graft to the perimetercomprises inserting the stratiform osteochondral graft through the boneport.
 11. A method of fabricating a stratiform osteochondral graft totreat an osteochondral defect, the method comprising: determining alocal cartilage topography or a local subchondral bone topographysurrounding a perimeter of the osteochondral defect; shaping a bonegraft material; forming a stratiform osteochondral graft by compressinga tissue graft material against the bone graft material; and causing asurface of the tissue graft material to match the local cartilagetopography or the local subchondral bone topography.
 12. The method ofclaim 11, wherein the bone graft material is selected from a groupconsisting of autograft bone, allograft bone, xenograft bone,demineralized bone matrix, bone graft substitutes, extracellular matrix,bone cells, growth factors, blood derivatives, bone marrow aspirate,synthetic bone, and combinations thereof.
 13. The method of claim 11,wherein the tissue graft material is selected from a group consisting ofautograft cartilage, allograft cartilage, xenograft cartilage,extracellular matrix, tissue scaffolds, cartilage cells, cell sheets,biological glues, growth factors, blood derivatives, bone marrowaspirate, synthetic cartilage, or combinations thereof.
 14. The methodof claim 11, wherein shaping the bone graft material comprises causing asurface of the bone graft material to match the local cartilagetopography or the local subchondral bone topography.
 15. The method ofclaim 11, wherein: shaping the bone graft material comprises compressingthe bone graft material with a first compression force; causing thesurface of the tissue graft material to match the local cartilagetopography or the local subchondral bone topography comprisescompressing the tissue graft material with second compression force; andthe first compression force is higher than the second compression force.16. The method of claim 11, wherein causing a surface of the tissuegraft material to match the local cartilage topography or the localsubchondral bone topography comprises: causing a bone graft materialsurface of the bone graft material to match the local subchondral bonetopography; and causing a tissue graft material surface of the tissuegraft material to match the local cartilage topography.
 17. A method ofdelivering a stratiform osteochondral graft to a bone tunnel in a bone,the method comprising: securing a bone port proximal end and/or a boneport distal end of a bone port to the bone; securing a delivery tubedistal end of a delivery tube to the bone port proximal end, thedelivery tube containing a stratiform osteochondral graft; anddelivering the stratiform osteochondral graft to the bone tunnel fromthe delivery tube through the bone port.
 18. The method of claim 17,further comprising, after delivering the stratiform osteochondral graftto the bone tunnel, moving the stratiform osteochondral graft throughthe bone tunnel such that a surface of the stratiform osteochondralgraft matches a local cartilage topography or a local subchondral bonetopography surrounding an internal opening of the bone tunnel.
 19. Themethod of claim 18, further comprising, prior to delivering thestratiform osteochondral graft to the bone tunnel, fabricating thestratiform osteochondral graft by shaping the stratiform osteochondralgraft such that, with the stratiform osteochondral graft in the bonetunnel, the surface is positionable to match the local cartilagetopography or the local subchondral bone topography.
 20. The method ofclaim 17, wherein the stratiform osteochondral graft comprises a bonegraft material and a tissue graft material.
 21. The method of claim 20,wherein the bone graft material is selected from a group consisting ofautograft bone, allograft bone, xenograft bone, demineralized bonematrix, bone graft substitutes, extracellular matrix, bone cells, growthfactors, blood derivatives, bone marrow aspirate, synthetic bone, andcombinations thereof.
 22. The method of claim 20, wherein the tissuegraft material is selected from a group consisting of autograftcartilage, allograft cartilage, xenograft cartilage, extracellularmatrix, tissue scaffolds, cartilage cells, cell sheets, biologicalglues, growth factors, blood derivatives, bone marrow aspirate,synthetic cartilage, or combinations thereof.